Trial · NCT04139018
Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia
NCT04139018, Phase 2, Completed, Washington University School of Medicine; results first posted 2021-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia. Trials, record NCT04139018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04139018
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Timolol Gel for Epistaxis in Hereditary Hemorrhagic Telangiectasia
- NCT number
- NCT04139018
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Hereditary Hemorrhagic Telangiectasia
- Interventions
- Timolol Gel, Placebo Gel
- First posted
- 2019-10-25
- Last updated
- 2021-08-24
- Results first posted
- 2021-08-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Assisted Epistaxis Severity Scale (aESS) Score From Baseline at 8 Week Follow-up | Baseline to 8-week follow-up | Assessment of epistaxis severity will be obtained by the validated instrument, the Epistaxis Severity Score (ESS). To complete the ESS, patients are asked to consider typical symptoms over the previous 3 months. The ESS contains 6 items - frequency, duration, and intensity of nosebleeds, whether patient has sought medication attention, whether patient is anemic, and whether patient has received a blood transfusion. The overall score ranges from 0 to 10, with severity of nosebleed based on score graded as None composite score of 0-1, Mild 1-4, Moderate 4-7, and Severe as 7-10.The minimal important difference noticeable by both patients and clinicians in the ESS scoring system is estimated as a change of 0.71. The scoring and MCID of the aESS is the same as the ESS. The aESS references a participant's epistaxis over the past 1 month, and the change in aESS was calculated as the aESS score at 8 weeks minus the aESS score at baseline. |
| Secondary | Number of Participants With Improved Response on Clinical Global Impression - Improvement (CGI-I) Scale | Scores at 8-week follow-up only | CGI-I is a global rating of improvement scale, which requires subjects to rate their degree of improvement on a seven-point scale: "Compared to your condition at admission to the project \[prior to medication initiation\], how would you rate your overall response: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment." |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Assisted Epistaxis Severity Scale (aESS) Score From Baseline at 8 Week Follow-up | Baseline to 8-week follow-up | Analysis was used with intention-to-treat principles, so all patients enrolled with baseline data were included. Note: the screen fail participant within the timolol gel arm had no baseline data say they were excluded from the analysis. | units on a scale | MEDIAN |
| SECONDARY | Number of Participants With Improved Response on Clinical Global Impression - Improvement (CGI-I) Scale | Scores at 8-week follow-up only | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Assisted Epistaxis Severity Scale (aESS) Score From Baseline at 8 Week Follow-up | Timolol Gel Arm | 2.32 | Full Range 0.22 to 5.97 | units on a scale | |
| Change in Assisted Epistaxis Severity Scale (aESS) Score From Baseline at 8 Week Follow-up | Placebo Gel Arm | 1.96 | Full Range -0.91 to 5.98 | units on a scale | |
| Number of Participants With Improved Response on Clinical Global Impression - Improvement (CGI-I) Scale | Timolol Gel Arm | No Change | 0 | Participants | |
| Number of Participants With Improved Response on Clinical Global Impression - Improvement (CGI-I) Scale | Placebo Gel Arm | No Change | 1 | Participants | |
| Number of Participants With Improved Response on Clinical Global Impression - Improvement (CGI-I) Scale | Timolol Gel Arm | Slightly Improved | 4 | Participants | |
| Number of Participants With Improved Response on Clinical Global Impression - Improvement (CGI-I) Scale | Placebo Gel Arm | Slightly Improved | 3 | Participants | |
| Number of Participants With Improved Response on Clinical Global Impression - Improvement (CGI-I) Scale | Timolol Gel Arm | Much Improved | 7 | Participants | |
| Number of Participants With Improved Response on Clinical Global Impression - Improvement (CGI-I) Scale | Placebo Gel Arm | Much Improved | 8 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Timolol Gel Arm | 14 | |
| Overall Study | STARTED | Placebo Gel Arm | 13 | |
| Overall Study | COMPLETED | Timolol Gel Arm | 11 | |
| Overall Study | COMPLETED | Placebo Gel Arm | 12 | |
| Overall Study | NOT COMPLETED | Timolol Gel Arm | 3 | |
| Overall Study | NOT COMPLETED | Placebo Gel Arm | 1 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Shortness of breath | Respiratory, thoracic and mediastinal disorders | Timolol Gel Arm | 1 | 14 | |
| other | Shortness of breath | Respiratory, thoracic and mediastinal disorders | Placebo Gel Arm | 0 | 13 | |
| other | Dizziness | Vascular disorders | Timolol Gel Arm | 1 | 14 | |
| other | Dizziness | Vascular disorders | Placebo Gel Arm | 0 | 13 | |
| other | Nasal congestion | General disorders | Timolol Gel Arm | 3 | 14 | |
| other | Nasal congestion | General disorders | Placebo Gel Arm | 0 | 13 | |
| other | Headache | General disorders | Timolol Gel Arm | 1 | 14 | |
| other | Headache | General disorders | Placebo Gel Arm | 1 | 13 | |
| other | Rhinorrhea | General disorders | Timolol Gel Arm | 1 | 14 | |
| other | Rhinorrhea | General disorders | Placebo Gel Arm | 0 | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Timolol Gel Arm | 0 | 14 |
| Total, all-cause mortality | Placebo Gel Arm | 0 | 13 |
| Total, other adverse events | Timolol Gel Arm | 7 | 14 |
| Total, other adverse events | Placebo Gel Arm | 3 | 13 |
| Total, serious adverse events | Timolol Gel Arm | 0 | 14 |
| Total, serious adverse events | Placebo Gel Arm | 0 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32940653 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Timolol Gel Arm vs Placebo Gel Arm: deaths from any cause | Trial comparisons |
| Timolol Gel Arm vs Placebo Gel Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04139018
GET https://conductscience.org/api/trials/v1/NCT04139018/registered